This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Treatment azithromycin
Phase phase 4
Sponsor Odense University Hospital
Start date May 2001
End date December 2007
Trial size 800 participants
Trial identifier NCT00132860, ProToCOL


The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:

- A slower rate of decline in forced expiratory volume in one second (FEV1);

- A reduction in the frequency and severity of exacerbations;

- Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);

- Lower mortality;

- An improved quality of life as compared to a group of placebo treated patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

change in postbronchodilator FEV1
time frame:

Secondary Outcomes

number of hospital admissions and number of hospital days
time frame:
time frame:
quality of life
time frame:
use of medication
time frame:
prevalence of respiratory pathogens
time frame:
prevalence of macrolide resistance
time frame:
inflammatory parameters
time frame:

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years. - Current or ex-smoker - Postbronchodilator FEV1 < 60% in stable condition (> 4 weeks after hospitalisation) - < 300 ml bronchodilator reversibility in FEV1 Exclusion Criteria: - Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest). - Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient. - Patients with pulmonary malignancy - Patients with other pulmonary diseases than COLD. - Patients with immunodeficiency. However, COLD patients treated with steroids can be included. - Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia. - Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis). - Patients with known allergy or intolerance to azithromycin - Pregnant or breastfeeding women - Manifest heart, liver or renal insufficiency - Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.

Additional Information

Official title Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin
Principal investigator Svend S Pedersen
Description Study Population: Patients with moderate to severe chronic obstructive lung disease. Trial Phase: IV Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial. Study Medicine: Azithromycin. Drug Administration: Oral. Drug Dose: 500 mg once daily for 3 days every month. Duration of Treatment: 3 years Number of Evaluable Patients: 200 per treatment arm Number of Included Patients: 400 per treatment arm, 800 patients in total.
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by Odense University Hospital.